Single High-dose of Liposomal Amphotericin B in Combination With B/F/TAF for HIV/AIDS-associated Talaromycosis

NANot yet recruitingINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

January 5, 2026

Study Completion Date

May 1, 2026

Conditions
HIV/AIDS-associated Talaromycosis
Interventions
DRUG

Amphotericin B

After enrollment, participants will be 1:1 randomly assigned into two groups for induction therapy after informed consent: single high-dose L-AmB group (10 mg/kg single intravenous dose of L-AMB) and control group (amphotericin B deoxycholate(AmBD) at 0.5-0.7 mg/kg/d intravenously for 14 days as the standard of care recommended by local guidelines).Thereafter, all participants in both groups will start consolidation therapy within 24 hours of the induction treatment, 200mg itraconazole(or voriconazole) q12h will be given for 10 weeks. After consolidation therapy, all participants will take oral itraconazole 200mg qd as secondary prophylaxis until their CD4+ cell counts are higher than 100cells/mm3 for at least 6 months. For the antiretroviral therapy, all participants will start B/F/TAF qd within 7 days after initiating antifungal therapy

DRUG

AmBisome

After enrollment, participants will be 1:1 randomly assigned into two groups for induction therapy after informed consent: single high-dose L-AmB group (10 mg/kg single intravenous dose of L-AMB) and control group (amphotericin B deoxycholate(AmBD) at 0.5-0.7 mg/kg/d intravenously for 14 days as the standard of care recommended by local guidelines).Thereafter, all participants in both groups will start consolidation therapy within 24 hours of the induction treatment, 200mg itraconazole(or voriconazole) q12h will be given for 10 weeks. After consolidation therapy, all participants will take oral itraconazole 200mg qd as secondary prophylaxis until their CD4+ cell counts are higher than 100cells/mm3 for at least 6 months. For the antiretroviral therapy, all participants will start B/F/TAF qd within 7 days after initiating antifungal therapy.

All Listed Sponsors
lead

Shanghai Public Health Clinical Center

OTHER_GOV